Defective Guidant Implantable Cardiac Defibrillators and Pacemakers

Implantable Cardiac Defibrillators are devices placed in the body intended to prevent cardiac arrest from a severe irregular heart beat.  A wire (lead) is attached to the heart and is connected to a miniature computer that contains its own power source that is placed under the skin usually in the area in the upper chest The device monitors the heart beat and is intended to react to changes in the heart beat. The built-in pacemaker replaces the hearts normal pacing system and restores normal heart rhythm. In some situations the device will deliver an electrical shock to the heart to wither restart or reset the heart rate.

Guidant Corporation
Guidant refers to itself as a world leader in the design and development of cardiovascular medical products. It is presently in on going talks to be acquired by Johnson & Johnson or ST. Jude Medical.  It is one of the major manufacturers of implantable medical devices, including defibrillators.

The Defects
On June 17, 2005, Guidant announced that it was recalling 46,000 of its implantable defibrillator. It advised that a tiny switch inside the device was prone to malfunction and would prevent the device from providing the electrical pulse needed for proper pacing. Guidant has been the focus of multiple news stories and FDA and Justice Department scrutiny as a result of its actions involving the manufacture, sales and marketing of these devices. Since June 17, 2005 Guidant has announce additional recalls covering another 75,000 devices including its Insignia brand of Pacemakers.

ICDs (implantable cardioverter defibrillators)
· Contak Renewal (Model H135), manufactured on or before August 26, 2004.
· Contak Renewal (Model H155), CRT-D, manufactured on or before August 26, 2004.
· Contak Renewal AVT
· Contak Renewal 3
· Contak Renewal 4
· Ventak Prizm 2 DR (Model 1861), manufactured on or before April 16, 2002.
· Ventak Prizm AVT
· Vitality AVT
· Renewal 3 AVT
· Renewal 4 AVT
· Renewal RF

Pacemakers
· Pulsar MAX (Models 1170, 1171, 1270)
· Pulsar (Models 0470, 0870, 0970, 0972, 1172, 1272)
· Discovery (Models 1174, 1175, 1273, 1274, 1275)
· Meridian (Models 0476, 0976, 1176, 1276)
· Pulsar Max II (Models 1180, 1181, 1280)
· Discovery II (Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286)
· Contak TR (Model 1241)
· Virtus Plus II (Model 1380, 1480)
· Intelius II (Model 1483, 1484, 1485, 1384, 1385, 1349, 1499)
· Insignia